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The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A : Alteplase | Experimental | Intravenous injection of Alteplase and one tablet of placebo |
|
| B : Acetylsalicylic Acid | Active Comparator | one tablet of Acetylsalicylic Acid and one dose of IV placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug | alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| visual acuity (VA) improvement after treatment | Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Number, type and grade of severity of adverse drug reactions | 3 months |
| Proportion of blindness patients after treatment | Blindness is defined according to WHO revised categories of visual impairment, as VA < 1/20 (< 20/400 or > 1.3 log.MAR) or visual field < 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit GUILLON, Dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Annecy | France | ||||
| CHU Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41109232 | Derived | Preterre C, Gaultier A, Obadia M, Vignal C, Mourand I, Plat J, Sablot D, Gaudron M, Rodier G, Godeneche G, Urbanczyk C, Marc G, Massardier E, Adam S, Boulanger M, Marcel S, Mechtouff L, Ronziere T, Calviere L, Godard-Ducceschi S, Barbin L, Lebranchu P, Guillon B; THEIA collaborators. Intravenous alteplase versus oral aspirin for acute central retinal artery occlusion within 4.5 h of severe vision loss (THEIA): a multicentre, double-dummy, patient-blinded and assessor-blinded, randomised, controlled, phase 3 trial. Lancet Neurol. 2025 Nov;24(11):909-919. doi: 10.1016/S1474-4422(25)00308-4. | |
| 39614619 |
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|
| acetylsalicylic acid | Drug | one tablet of aspirin 300 mg |
|
|
| Placebo Oral Tablet | Drug | One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid |
|
|
| placebo IV | Drug | IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour |
|
|
| 1 month |
| Visual field | Visual field at 3 months. | 3 months |
| Time course of VA on ETDRS chart or ordinal scale | 3 months |
| Time-to-treatment administration impact on VA evolution. | Mean VA improvement according to the time between onset of sign and treatment administration | 1 month |
| Global disability (modified Rankin scale) after treatment | 3 months |
| Quality of life related to vision (NEI-VFQ-25) after treatment | 3 months |
| Caen |
| France |
| CH métropole Savoie | Chambéry | 73000 | France |
| CHD Vendée | La Roche-sur-Yon | 85000 | France |
| CH de La Rochelle | La Rochelle | 17019 | France |
| CHU | Lyon | France |
| CHU de Montpellier | Montpellier | 34295 | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU de Nice | Nice | 06001 | France |
| Fondation Ophtalmologique Rothschild | Paris | 75019 | France |
| Ch Perpignan | Perpignan | France |
| CHU de Rennes | Rennes | 35033 | France |
| CHU Rouen | Rouen | France |
| CH de Saint Nazaire | Saint-Nazaire | 44606 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| CHU de Tours | Tours | 37044 | France |
| CH Vannes | Vannes | France |
| Derived |
| Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24. |
| ID | Term |
|---|---|
| D015356 | Retinal Artery Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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